Simin Saffaripour
About Simin Saffaripour
Simin Saffaripour is the Associate Director of Clinical Quality Assurance at Alkermes, overseeing oncology studies and ensuring compliance with Good Clinical Practice guidelines.
Title
Simin Saffaripour serves as the Associate Director of Clinical Quality Assurance at Alkermes, located in Waltham, Massachusetts, United States.
Current Role at Alkermes
In her role as Associate Director of Clinical Quality Assurance at Alkermes, Simin Saffaripour is responsible for overseeing six oncology studies within the oncology program. She performs essential quality assurance activities ensuring that clinical trials adhere to Good Clinical Practice (GCP) guidelines. Additionally, she conducts domestic and international Investigative Site Audits, Internal Process Audits, TMF Audits, and GCP Document Audits.
Previous Positions at Alkermes
Simin Saffaripour has held multiple roles at Alkermes, including Manager of Clinical Quality Assurance, Quality Compliance from 2018 to 2021. She also worked as a Senior Clinical Associate in Clinical Quality Assurance, Quality Compliance from 2016 to 2017. Her responsibilities included developing audit plans, collaborating with various parties to close out audit observations, and providing CAPA oversight.
Experience in Clinical Trials
Simin Saffaripour has extensive experience in clinical trials, having worked at the Dana-Farber Cancer Institute from 2005 to 2016. At Dana-Farber/Harvard Cancer Center, she was involved in Clinical Research Audit & Monitoring. Her earlier roles included serving as a Cancer Clinical Trials Manager at Beth Israel Deaconess Medical Center from 2003 to 2005, where she managed cancer clinical trials.
Educational Background
Simin Saffaripour has a Master of Public Health (MPH) from Boston University, School of Public Health, where she studied Health Services from 2000 to 2003. She also obtained a Master of Science (MS) in Biochemistry from Illinois State University from 1985 to 1987.
Early Career and Lab Management
Before her involvement in clinical trials, Simin Saffaripour worked at the Center for Blood Research, an affiliate of Harvard Medical School, as a Lab Manager from 1994 to 2003. Here, she gained significant laboratory management experience over a span of nine years.